On April 10, 2019, the XI Scientific and Practical Conference “State Regulation and the Russian Pharmaceutical Industry 2019: Continuing the Dialogue” was held in Moscow. The event was attended by representatives of regulatory bodies, expert organizations, pharmaceutical companies, industry associations and trade unions.
The theme of the first session was “The system of drug support – the key to achieving the goal of the national drug policy”. The second session was devoted to improving legislation in the field of drug circulation.
Within the framework of the final dialogue “Actual issues of the implementation of national projects from the position of & nbsp; & nbsp; participants of the pharmaceutical market ”, participants discussed the topics of pricing, ensuring the rational and safe use of drugs, state quality control in the field of drug circulation, intellectual property, interchangeability, as well as the results of experiments on the implementation of a monitoring system.
The moderator was Anna Plesovskikh , general director of the intersectoral association Pharmaceutical Run: “Lawmaking is gaining momentum. We communicate with many manufacturers and understand that often this process runs ahead without feeling how the community lives. Therefore, it is important for us to be aware of what mechanisms are operating in the market, what participants see, how they operate and how this compares with the introduction of legislative initiatives. ”
Evgeny Nifantiev , Neo-Farm CEO, Chairman of the Coordinating Council of the Russian Association of Pharmacy Networks (RAAS), spoke from the point of view of the pharmacy market about the shortcomings of the terms of reference prepared by a subgroup of the inter-faction working group to improve legislation in the field drug provision of citizens and circulation of drugs. The expert expressed hope for the transformation of the terms of reference taking into account the views of the pharmacy segment.
An extensive report on the experiment on the introduction of labeling in production was made by Andrei Bulatov , director of the Polisan pharmaceutical plant. In the conclusions, he said that cryptocode significantly affects the efficiency of automatic packaging lines and production in general. Among the reasons, he noted frequent line stops due to clogged nozzles of cartridges, an increase in the number of defects and the need to switch to high-quality imported cardboard.
Margarita Mustafina , the head of the group for ensuring the quality of products circulation at Novartis Group of Companies, as the leader of subgroups 7VZN and improving business processes based on Roszdravnadzor, made several suggestions on the labeling system. This is printing testing using cryptocode, testing the transfer of crypto data in the MDLP system for all participants, registering in MDLP all subjects of circulation, describing drugs by manufacturers and holders of RUs, finalizing the classifiers reference books as the foundation of the project, improving reporting requirements and developing organizational and legal interaction principles.
Marking was continued by Anton Kharitonov , the head of the Pharma product line at the Center for the Development of Advanced Technologies, telling about emission registrars and the process of their implementation from receipt to full use, as well as about changing the length of electronic signatures, enterprises’ readiness for 7ВЗН and the readiness of pharmacies and hospitals for the mandatory implementation of the system from 01/01/2020.
Andrei Akhantiev , director of economic security at GEROPHARM, shared his opinion on the initiative to introduce price preferences of 25% for government procurement of drugs for local manufacturers of full-cycle drugs, and talked about enforcement problems in this area for the first quarter of 2019.
Olzhas Satybaldin , the head of the government relations department at AstraZenaka Russia and Eurasia, summed up the event and noted that this and the coming year a peak load on pharmaceutical manufacturers is expected: mandatory drug labeling, changing the order of entry drugs into civilian circulation, as well as changes in the approach to pricing. The expert also recalled the low level of harmonization of Russian procedures with the EAEU and a number of questions about GMP.
Varvara Kazhberova , director of the Media Institute for Public Health, supplemented the discussion with the topic of mass media: advertising of over-the-counter medicines, ethics and medicine, as well as commented on the prospects of legalizing the remote sale of medicines. She noted problems with the ethics and correctness of the information the patient receives, as well as the onset of the ethical crisis due to vague values and lack of clear standards. The speaker took the initiative to create a single resource that patients could trust.